BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUAL CHAMBER SYRINGE SEALER

    MDR report key: 12671855 · Received October 21, 2021

    Report

    Report Number
    2320721-2021-00083
    Event Type
    Injury
    Date Received
    October 21, 2021
    Report Date
    October 20, 2021
    Product Code
    KIF
    PMA / PMN Number
    K960548
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE THERE IS NO INDICATION THAT THE RIBBON USED MALFUNCTIONED, BECAUSE THIS EVENT MAY RESULT IN PERMANENT DAMAGE TO A BODY FUNCTION/STRUCTURE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT RIBBON SEALER EXTRUDED PAST A PATIENT'S APEX, AND THE PATIENT WAS FEELING PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1570276 DUAL CHAMBER SYRINGE SEALER RIBBON KIF

    Patients

    Seq Age Sex Outcome Treatment
    1